Study to Evaluate Effects of a Weight Loss Program in Different Formats on Healthy Adults

This is an interventional treatment trial for Overweight and Obesity focused on measuring Weight Loss, Obesity, Overweight Read More

Inclusion Criteria:

1. Subject is male or female, 18-70 years of age, inclusive.
2. Subject has a body mass index (BMI) of 25.00 to 44.99 kg/m2, inclusive, at visits 1 and 2 (weeks -1 and 0).
3. Subject has no plans to change smoking habits during the study period.
4. Subject is willing to follow study program instructions, including avoidance of all non-study-related food and beverages.
5. Subject is willing and able to comply with the visit schedule [i.e., no visit window will be allowed between visits 2 and 3 (week 0 and 1) and visits 3 and 4 (weeks 1 and 2)].
6. Subject agrees to follow the physical activity recommendations as outlined in each plan.
7. If a premenopausal female, subject has a history of regular menstrual cycles that range in length from 21 to 35 d, where applicable.
8. Judged to be in good health on the basis of medical history and screening laboratory assessments.
9. Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators.

Exclusion Criteria:

1. Subject has an abnormal laboratory test result of clinical significance at visit 1 (week -1), at the discretion of the Investigator. One re-test will be allowed on a separate day prior to visit 2 (week 0) for subjects with abnormal laboratory test results.
2. Subject has had a weight loss or gain ≥10 lb (4.5 kg) in the 6 months prior to visit 1 (week -1).
3. Subject has used weight loss medications within 6 months of visit 1 (week -1) or weight loss supplements or programs, other than those provided, intended to alter body weight within 4 weeks of visit 1 (week -1) or during the course of the study (Appendix 1).
4. Subject has extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian), in the opinion of the Investigator.
5. Subject has a known allergy, sensitivity, or intolerance to the study foods or any ingredients of the study menu provided.
6. Subject has diagnosed diabetes mellitus (type 1 or type 2) or fasting glucose ≥126 mg/dL at the screening visit (visit 1, week -1).
7. Subject has used thyroid hormones, except stable-dose replacement therapy for ≥2 months prior to visit 1 (week -1; Appendix 1).
8. Subject has used dietary supplements that, in the judgment of the Investigator, are likely to markedly affect appetite. The washout period will be 2 weeks prior to visit 1 (week -1; Appendix 1).
9. Subject has used medications or supplements that may influence carbohydrate metabolism, including but not limited to hypoglycemic medications and systemic (intravenous, intramuscular, or oral) or ≥1500 µg/d topical (inhaled, intranasal, or dermal) corticosteroids within 4 weeks of visit 1 (week -1) and throughout the study (Appendix 1).
10. Subject has a history or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, or neurologic disorders.
11. Subject has an active gastrointestinal disorder such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
12. Subject has an active infection or signs/symptoms of an infection. The baseline visit (visit 2, week 0) will be re-scheduled to allow subject to be symptom-free of any type of systemic infection for at least 5 days.
13. Subject has a history of gastrointestinal surgery for weight reducing purposes.
14. Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg as defined by the blood pressure measured at visit 1 (week -1). One re-test will be allowed on a separate day prior to visit 2 (week 0) for subjects whose blood pressure exceeds either of these cut points at visit 1.
15. Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
16. Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document.
17. Subject is a premenopausal female using a form of hormonal contraception that does not result in a normal menstrual cycle, including a regular menses period.
18. Subject has a recent history of (within 12 months of visit 1, week -1) or strong potential for alcohol or substance abuse. Alcohol abuse defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
19. Exposure to any non-registered drug product within 30 d prior to the screening visit (visit 1).
20. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.